Which PD1 or PDL1 trial for NSCLC? - 1258300

Fri, 07/26/2013 - 17:20

Looks like there are four companies doing pd1 / pdl1 trials. Any insight into whether one pd1 / pdl1 trial is better than another? It appears Merck is starting one at UCSF now and Roche at Stanford sometime in the future. Is there something we should be looking for? Would be used as first line instead of traditional three drug chemo treatment.

NSCLC, Adenocarcinoma 2A Feb 2012, Male Non Smoker 47, surgery and chemo. Reoccurrence in lung July 2013. Brain and bone scan clean.

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Dr West

I would be very wary about trying to draw conclusions based on so little information thus far. I would consider it like reading tea leaves -- the concept is appealing, but there's way too little data to compare one to another yet. Most expects are justifiably disinclined to start calling the likely outcome of the game in the first inning.

-Dr. West

Dr West

Absolutely. I'd actually probably favor one that has already demonstrated encouraging results, such as nivolumab or MPDL3280A, vs. one that hasn't demonstrated any clinical activity in lung cancer yet.

-Dr. West



It sounds as if you're in Northern Cal? All things being equal, you could narrow it down to convenience and eligibility criteria. Trial phase is important as well, as higher phases generally mean more data, but also include more stringent entry criteria. As this is first-line, and assuming your performance status is excellent, it will come down to whether your tumor tissue expresses PD-1 or PD-L1. Note that the Merck trial requires a fresh biopsy, whereas I believe the Genentech trial can use already existing tissue samples.

I was previously aiming for the Merck trial as it's close to home, but the Genentech/Roche trial is Phase II, and early data suggests its mechanism of action may prevent pneumonitis, one of the concerning potential side effects of the current anti-PD1 agents. See http://www.cancernetwork.com/conference-reports/aacr2013/content/articl…

BTW, the Angeles Clinic in Santa Monica is already recruiting for the Genentech trial. Anyone else out in GRACEland with more info, please comment!

Best of luck!


Yes in the Bay Area so UCSF, Stanford and others all reasonable. Have first appointment on Monday at UCSF to find out more about trial. Confirmed that UCSF trial is with Merck and another biopsy is required. Biopsy from early July was not sufficient for biomarker testing and had to use 18 month old tumor which did not show EGFR or ALK. Would like to run the new biopsy through biomarker testing at the same time if at all possible.

Thanks for the info on pneumonitis. Important consideration and something will ask primary doctor about.

You all are great. Thanks for taking the time.


Dear Jazz and Gaw1

I live in the Bay Area too and checked out the UCSF trial. Since I am with Kaiser, they won't cover Phase 1 clinical trials. HOWEVER, my onc told me that Kaiser will probably be having their own anti-PD1 trial in Kaiser - Phase 2, starting possibly September. They are in the process of approving it. So if you happen to be a Kaiser member like me, you should wait and ask about it. I don't know which agent they will be using but I don't think I have any preference at this time.




That's a hot tip! SoCal KP is so different, I can't imagine they'll be offering that trial here, but I'll ask. Please keep us posted if/when you find out.

When I was at KP Walnut Creek, my onc said Phase 1 trials can be approved but one has to go through the appeals process. The Colorado trial I was on last year was a Phase 1b, and it was approved through normal channels (maybe because I said it was Phase II and no one checked?). The doc at UCLA tells me there are a number of KP patients on their Phase 1 trials, but I'm sure they don't know the coverage (Individual, corporate, Medicare Advantage?), so it's possible, if not easy.

The Stanford PD-L1 trial (Genentech) is Phase II. I speak to a coordinator next week so perhaps I can learn when that trial opens.

Have you found anything to soothe the scalp? How are you?


Are you in scal?
I heard Kaiser trial is with roche drug
As for my burning scalp, pls check my post under "low dose tarceva". Septra is working great for me so far. It helps to decrease the inflammation

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Lung specialist is Matthew Gubens MD out of the UCSF Thoracic Surgery and Oncology department. Doctor running the study appears to be Adil Daud MD out of the UCSF Melanoma Center.

Feisty D is an inspiration and it was great to read the latest update from earlier this month. Thanks for sharing that link.


Thanks Jazz. That's the one I remember finding about 53 google searches ago but couldn't seem to find again. I use MS OneNote to keep track of everything but hadn't been copying the trial numbers down at the time. Thank you!!!


gaw1, you probably know this but clinical trials . gov has an excellent advanced search feature that may be helpful in finding possibly all the pd 1 and pd l1 trials since they're all fairly new.


Thanks Catdander. I've been on the clinical trials . gov site and the one from the National Cancer Institute. I need to be more judicious keeping track of what I'm searching on ... treatment, drug number, drug name, etc. I saw the NCT01846416 one time and for the life of me, couldn't find it again. Easy to lose track. Which is why GRACE is so GREAT! Thanks for the reminder/lead. I've bookmarked the url.

Appears one part of the Merck trial will test 10mg every two weeks versus every three weeks. I assume when on a trial you are randomly assigned one of these groups. Looks like in the melanoma trials the two weekers had better response but more side effects. Any other insights into whether two weeks versus three weeks is better? Too early to tell? If the two weekers are responding better, do they at some point move the three weekers to the two week time frame? Sorry if that is a trial newbie question.


No not a trial newbie question. Each trial is set up with their own rules so whether the 3 weekers get to move to 2 weeks isn't an obvious known. Hopefully if it's found that one is better than the other the others get a chance at the better regimen. It depends on what they're looking at as an end result too. Sometimes they want to look at long term effects in which case a crossover wouldn't be done at least not in the early stages of the trial.

I really don't know a lot about trials, haven't been involved with any so I'm speaking mostly as a reader of Grace and no other real resources. But Grace does rock, I agree.


Jazz, another excellent tip :wink: , "The Colorado trial I was on last year was a Phase 1b, and it was approved through normal channels (maybe because I said it was Phase II and no one checked?)."


RE: gaw1. I think it is great that you are looking at clinical trials.

I suggest that phase II/III is not necessarily 'better' than Phase I. In Phase I, you are guaranteed to get the investigational agent, whereas some Phase II/III trials may randomize you to standard chemotherapy.
Similiarly, I would not base your decision on the Phase I vs II terminology either. It provides little indication of how far the drug is in development. For example, Checkmate 012 is a 'Phase I' trial with 13 different arms and 220 lung cancer patients, and before it, the original Phase I had 306 patients.

Also be aware that some, but not all, of the trials you are viewing may require prior systemic therapy for eligibility.

Just for example, our center has several PD1/PDL1 trials accruing treatment-naive lung patients where all participants get treated with investigational agent.

http://www.clinicaltrials.gov/ct2/show/NCT01846416 (MPDL3280A)

http://www.clinicaltrials.gov/ct2/show/NCT01693562 (MEDI4736, this is accruing a lung cohort)

http://www.clinicaltrials.gov/ct2/show/NCT01454102 (nivolumab, aka BMS 936558)

http://www.clinicaltrials.gov/ct2/show/NCT01295827 (lambrolizumab, aka MK-3475)

Note that this message is not intended to recruit anyone to any clinical trial, or recommend any trial over another. Just giving you a sense of the trials that are available in lung cancer. Hope this helps.


Dr. Creelan - I appreciate your insight and overview. It helps with understand what I'm reading. Had appointment with UCSF. Waiting for biopsy and to see if a PD-L1 expression is identified, for part F where currently slotted. I think Part C is for those without PD-L1 expression but there are very few slots and unclear if any of them are open at UCSF.



My wife, who is Stage IV spindle cell carcinoma and has completed first round of 6 carbo/taxol/avastin infusions is ready for maintenance and we are considering the University of Pennsylvania Merck trial MK-3475 (we are only 15 minutes away and already using Penn Oncology). We also know of the one other spindle cell person in LA (mentioned above) and have been corresponding with her about her anti-PD1 trial and are heartened by her response. I also saw Dr West commenting on a video about PD1 that there have been remarkable response anecdotally for spindle cell and other sarcomatoid patients from anti-PD1 trials. Opinions about this trial?


Dr West

I'm sorry about your mother's diagnosis. I can't speak to what immune checkpoint inhibitor might be best, and I believe that the stray cases here and there of spindle cell and other sarcomatoid NSCLC patients have been seen with various anti-PD1 therapies rather than any single drug. I'm not sure of anti-PDL1, but overall I don't think there's any reason to favor a faraway option over a closer one and am hopeful about this entire class of agents for patients such as your wife, with spindle cell carcinoma.

Good luck!

-Dr. West


I'm looking to enroll for for PD/PD1 trial for my Dad -NSCLC -Squamous based out of India but most of clinical trial location or US or Europe. Any reference or email to contact Clinical Trial Group to check anything available for these part of the world (South east Asia).
Would Appreciate, if anyone can provide pointers/contact details to reach right people and check with them about clinical trials in India or closer location.